Patient Convenience Study (RE-SONANCE)
22 de maio de 2019 atualizado por: Boehringer Ingelheim
Non-interventional Study Describing Patients´ Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
9472
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Multiple Locations, Bulgária
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Multiple Locations, Eslovênia
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Multiple Locations, Estônia
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Multiple Locations, Federação Russa
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Multiple Locations, Hungria
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Multiple Locations, Israel
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Multiple Locations, Letônia
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Multiple Locations, Polônia
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Multiple Locations, Romênia
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Multiple Locations, Sérvia
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Multiple Locations, Tcheca
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Multiple Locations, Áustria
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
European patients with non valvular atrial fibrillation
Descrição
Inclusion criteria:
Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa according Summary of Product Characteristics and physician's discretion.
OR
Cohort B:
- B. Written informed consent prior to participation.
- B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
- B. Stroke prevention treatment initiated with Pradaxa or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria:
- Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Cohort A - VKA to Pradaxa switcher
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
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Cohort B - newly assigned to treatment
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Prazo: From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Prazo: From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
Prazo: Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
Prazo: Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
Prazo: Baseline
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CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke.
Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Score of < 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.
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Baseline
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Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
Prazo: Baseline
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HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation.
A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2.
A high score corresponds to a greater risk, while low score corresponds to a lower risk.
Data presented are percentage of patients with high and low risk.
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Baseline
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Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
Prazo: Baseline and up to 210 days
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Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine.
Creatinine is filtered from the blood by the kidneys and released into the urine.
A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection.
The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine.
Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).
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Baseline and up to 210 days
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Characterization of Patients With Respect to Comorbidities
Prazo: Baseline
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Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Data presented here are percentage of total patients with comorbidities.
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Baseline
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Characterization of Patients With Respect to Concomitant Therapies
Prazo: Baseline
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Concomitant therapies are two or more drugs used or given at or almost at the same time.
The data presented here are percentage of total patients for taking concomitant medication.
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Baseline
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Characterization of Patients With Respect to Dosing of Pradaxa
Prazo: Baseline and up to 210 days
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The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).
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Baseline and up to 210 days
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Duration in Months of Previous VKA Treatment
Prazo: Baseline
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The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.
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Baseline
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Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)
Prazo: Baseline
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This endpoint is not assessable as the necessary data was not collected in the database
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Baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Prazo: From 30 days up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).
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From 30 days up to 210 days
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Description of PACT-Q1 Items at Baseline
Prazo: Baseline
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Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy.
Following are the seven items from PACT-Q1.
The score range is 1-5.
Each question is analyzed individually, with higher score indicating better outcome.
A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots?
A2 - Do you expect that your AT will relieve some of the symptoms you experience?
A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding?
A4 - How important is it for you to have an AT that is easy to take?
A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself?
A7 - How concerned are you about how much you may have to pay for your AT?
For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.
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Baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de novembro de 2015
Conclusão Primária (Real)
1 de junho de 2017
Conclusão do estudo (Real)
1 de junho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de novembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de fevereiro de 2016
Primeira postagem (Estimativa)
18 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de maio de 2019
Última verificação
1 de maio de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1160.249
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .